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| Name | Class |
|---|---|
| Apple Medical Corporation | INDUSTRY |
This is a randomized controlled trial comparing the use of the Mobiusâ„¢ retractor to the use of traditional metal retraction instruments in non-urgent cesarean deliveries of obese women. The Mobiusâ„¢ retractor was designed for abdominal surgery to improve visualization of the surgical field through standard surgical incisions and is now a standard instrument used for cesarean deliveries at Thomas Jefferson University Hospital. We hypothesize that the use of the Mobiusâ„¢ retractor during cesarean deliveries in obese women decreases operative time, blood loss, number of transfusions, infectious morbidity, incision length, and intra- / post-operative antiemetic and pain medication use, while increasing surgeon satisfaction.
The Mobiusâ„¢ retractor has been used in many obese cesarean deliveries based on the theory that it provides superior visualization. There have been no clinical trials to determine if this "added" exposure offers any measurable significant benefits to justify the added cost. This study will determine if the Mobiusâ„¢ retractor does provide a measurable difference in outcomes, compared to the traditional retraction instruments.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobiusâ„¢ retractor | Device | |||
| traditional metal retraction instruments | Device |
| Measure | Description | Time Frame |
|---|---|---|
| operative time |
| Measure | Description | Time Frame |
|---|---|---|
| blood loss | ||
| number of transfusions | ||
| infectious morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason K Baxter, MD, MSCP | Contact | (215) 955-9238 | jason.baxter@jefferson.edu | |
| Edward J Hayes, MD | Contact | (215) 955-9196 | edwardjhayes@comcast.net |
| Name | Affiliation | Role |
|---|---|---|
| Jason K Baxter, MD, MSCP | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| incision length |
| intra and postoperative antiemetic medication use |
| intra and postoperative pain medication use |
| surgeon satisfaction |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |